The application for a listing license for the new drug Pamipalei of Baiji Shenzhou is included in the priority review.

Guide: Pamipali is the third innovative drug developed by Baiji Shenzhou, and has followed in the footsteps of The ® and Bai Yueze ®!---- baiji Shenzhou is a commercial biotech companyThe company announced today that the National Drug Administration of China (NMPA) Drug Review Center (CDE) has included in its new drug marketing license (NDA) for patients who have previously undergone at least two lines of chemotherapy and patients with advanced ovarian cancer, tubal tube cancer or primary abdominal cancer who have previously undergone at least two lines of chemotherapy, and with a suspected pathogenic BRCA mutation"Pamipali is the third innovative drug developed by Baiji Shenzhou, and it has followed the footsteps of Baizean ® and Bai Yueze ®, " said DrYu Yong, Chief Medical Officer of Oncology Immunology in Baiji ShenzhouParmipali's first new drug listing permit application could be quickly included in the priority review to show that there is currently an unmet treatment need in the patient population of this terminal diseaseWe will announce clinical data in support of the new drug's licensing application at a future medical conference and look forward to reaching the next milestone of the Pamipali development"It took only one week from acceptance to formal inclusion in the priority review, demonstrating the high efficiency of the National Drug Administration's Drug Review Center and a strong endorsement of our work," said MsNi Xiaojun, Senior Vice President of Baiji Shenzhou and Head of Global Pharmaceutical AffairsThe company's pharmaceutical affairs team will continue to work closely with the State Drug Administration and the Drug Review Center on this application, looking forward to bringing this innovative drug to the vast number of Chinese patients at an early date"The NDA, which is accepted in July 2020 for the treatment of patients with advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer, is based on key phase 2 clinical results of a Phase 1/2 clinical trial (NCT03333915) A total of 113 patients with high-level epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) or high-level endometrial-like epithelial cancer who had previously received at least two lines of standard chemotherapy, carrying BRCA1/2 mutations, or high-level endometrial-like epithelial cancer were involved in the trial in ChinaBaiji Shenzhou is conducting extensive clinical development of Parmipari as a monotherapy or in combination with other drugs to treat a variety of solid tumorsPriority review is a process established to strengthen drug registration management and to accelerate the market-oriented development and marketing of innovative drugs with clear clinical advantages and clinically urgent needsIn accordance with the Measures for the Administration of Drug Registration, which came into effect on 1 July 2020 (General Administration Order No27), the Drug Regulatory Authority will optimize the review procedures and review resources for the varieties that have been prioritized for review, and the approval time frame is expected to be shortenedOvarian cancer ranks 10th in the ranking of common cancers among Chinese womenIn 2018, there were more than 50,000 new cases and more than 30,000 deaths More than 60% of ovarian cancer patients are at the time of diagnosis Standard treatments for ovarian cancer include surgery and postoperative platinum chemotherapy More than 90% of ovarian cancer patients have epithelial ovarian cancer Of these, about 70% of patients with epithelial ovarian cancer will still have a recurrent disease after receiving first-line therapy and receiving complete remission Globocan 2018; Bray et al 2018 s ii? Independently developed by scientists from Baiji Shenzhou in the Beijing Research and Development Center, Pamipali is currently being developed globally as a monotherapy or in combination with other drugs to treat a wide range of malignant solid tumors To date, more than 1,200 patients have been enrolled in the Parmipale clinical trial Parmipali's application for a new drug for the treatment of ovarian cancer has been accepted by the National Drug Administration (NMPA) Drug Review Centre (CDE) and has been included in the priority review Clinical trials on ParmiPalei's clinical project PamiPalei include: Parmipale compared to placebo in China for the maintenance therapy of platinum-sensitive recurrent ovarian cancer patients (NCT03519230) Parmipali for the treatment of homologous recombination Phase 2 Clinical Trials for Defectmetary Metastatic Resistance Prostate Cancer Patients (NCT03712930) in China for the treatment of metastatic HER2-negative breast cancer patients with BRCA mutations (NCT03575) Parmipalei is used in Phase 2 clinical trials in China for the treatment of patients with advanced or non-surgical gastric cancer (NCT03427814) for the treatment of advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer or advanced tertiary Phase 1/2 Clinical Trials (NCT03333915) Parmipale combined radiotherapy and/or dimozole amine for the treatment of newly diagnosed or recurrent/refractive glial glioblastoma patients 1b/ Phase 2 Clinical Trials (NCT03150862) Pamipali Combined Dimoamine 1b Clinical Trials for The Use of Local Advanced or Metastatic Solid Tumors (NCT03150810) Parmipale United Bezean ® for the treatment of a number of Phase 1b Clinical Trials for Malignant Solid Tumors (NCT02660034) About Baiji Shenzhou is a global, commercial-stage biotech company focused on research, development, production and commercialization of innovative drugs to improve efficacy and drug accessibility for patients worldwide With more than 4,100 employees in Chinese mainland, the United States, Australia and Europe, The company is accelerating its diversified pipeline of new cancer therapies At present, two self-developed drugs in Baiji Shenzhou, BTK inhibitor BaiYueZe ® (Zebutini capsules) are being sold in the United States and China, anti-PD-1 antibody drug Bacaan ® (for relizumab injection) in China In addition, Baiji Shenzhou is selling or plans to sell a number of oncology drugs in China authorized by Amkin, New Base Logistics Co., Ltd (under The Company of Baxter Meishi Squibb) and EUSA Pharma